HIV treatment, Genvoya, gets FDA nod
The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment More...
Generic version of Nexium approved to treat GERD
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages More...
New warnings issued for Alzheimer’s drug, Aricept: Health Canada
New warnings have been added to the prescribing information for the Alzheimer’s drug Aricept (donepezil) advising of the risk of two rare but potentially serious conditions: muscle breakdown (rhabdomyolysis) and More...
Novartis psoriasis drug, Cosentyx, receives FDA approval
The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis. PsoriasisPublic domain image/Bodiadub Psoriasis is a skin condition that causes More...
Blood clot prevention drug, Savaysa, gets FDA approval
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation More...
Novo Nordisk’s Saxenda receives FDA approval for chronic weight management treatment
The U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The More...
Melanoma drug, Opdivo, gets FDA approval
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who More...
Ovarian cancer drug, Lynparza, receives FDA approval
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an More...
FDA warns of dangers of powdered pure caffeine
The US Food and Drug Administration (FDA) is advising the public about powdered pure caffeine that is sold on the internet and recommends people avoid these products. In an FDA Blog today, Director of FDA’s More...
FDA approves Obizur for treating hemophilia A bleeding episodes in adults
The U.S. Food and Drug Administration approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] More...
Sleep drug, Belsomra, gets FDA nod
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia). Belsomra is an orexin receptor antagonist and is More...
Type 2 diabetes drug, Jardiance, receives FDA approval
The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Diabetes symptomsPublic domain More...
Chikungunya and dengue fever anti-viral invented by Florida researcher
The Vaccine & Gene Therapy Institute of Florida (VGTI Florida®), a leading non-profit biomedical research institute, today announced a key milestone achievement in developing novel approaches for the prevention More...
COPD drug, Striverdi Respimat, receives FDA approval
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema More...
CLL drug, Imbruvica, receives FDA approval for expanded use
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which More...
Merck announces start of Phase III study of CMV drug, Letermovir
Merck announced today that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. The multicenter, randomized, placebo-controlled study More...
FDA approves Targiniq ER, extended-release oxycodone, to treat severe pain
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat More...
Gilead Sciences cancer drug, Zydelig, receives FDA approval
The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic More...
FDA approves Ruconest for the treatment of acute attacks in patients with hereditary angioedema
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema More...
Senators question Gilead Sciences CEO about pricey Hepatitis C drug, Sovaldi
Senate Finance Committee Chairman Ron Wyden, D-Ore., and senior Finance Committee member Chuck Grassley, R-Iowa, Friday requested detailed pricing information on a costly new Hepatitis C virus (HCV) drug. Wyden More...
